Evaluating point-of-care prothrombin time measurements for cardiac surgery

Evaluating point-of-care prothrombin time measurements for cardiac surgery - POC-PT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40525

Enrollment

Registered

2014-03-19

Start date

2014-04-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation status prothrombin time

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Ex-vivo study - Healthy volunteers - Age 18 * 90 years - Informed consent;Clinical study in cardiac surgery - Patients undergoing elective cardiothoracic surgery - Age 18-90 years - Preoperative hemoglobin of > 5.5 mmol/l - Informed consent

Exclusion criteria

Exclusion criteria: Ex vivo study - Subjects with hemostatic deficiencies or previous hemostatic problems - Subjects using vitamin K antagonists, clopidogrel or dabigatran at the time of surgery. - Pregnancy;Clinical study in cardiac surgery - Re-operations and emergency operations - Use of erythropoietin - Hepatic or renal failure

Design outcomes

Primary

Measure	Time frame
The International Normalized Ratio (INR) of the prothrombin time (PT) as measured with Coaguchek Plus or routine laboratory tests.	—

Secondary

Measure	Time frame
The ex vivo effect of different protamine:heparin ratio on the POC-PT.	—

Countries

Netherlands

Outcome results